DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia

Alzheimer Disease Clinical Trial

— DISPLAY  

Official title:

DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05768425
• Other study ID #: H-22046053
• Status: Active, not recruiting
• Start date: February 1, 2023
• Est. completion date: December 2032

Study information

• Verified date: October 2023
• Source: Danish Dementia Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.

Description:

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia. DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. A novel technique for the measurement of misfolded alpha-synuclein (aSyn) is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process. Objective: Determining which biospecimen alone or in conjunction with other biospecimens can most accurately discriminate patients with DLB from Alzheimer's disease (AD) assessed by RT-QuIC for aSyn. Design: Cross-sectional case-control study of the diagnostic accuracy of pathological alpha-synuclein assessed by RT-QuIC in different biospecimens (CSF, skin, olfactory mucosa, saliva, feces, and urine) from patients with DLB versus AD. Patients will also be scored with tests for cognitive function, dysautonomia, and movement disorders.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for healthy controls (HC):

• Age 18 - 40 years of age
• Able to cooperate as evaluated by the primary investigator (PI)
• Able to give informed consent Exclusion criteria
• Signs of neurological/psychiatric conditions
• Known genetic neurodegenerative disease in close family

Inclusion criteria for patients with Dementia with Lewy Bodies (DLB):

• Probable DLB (McKeith et al., 2017) or MCI-LB (McKeith et al., 2020)
• Age > 50 years of age
• Able to give informed consent
• Able to cooperate as evaluated by the PI
• MCI, mild or moderate dementia, and MMSE > 18

Exclusion criteria for patients with DLB:

• Patients not able to give informed consent.
• Current alcohol or drug abuse
• Terminal illness
• Diagnosed with major neurological/psychiatric conditions other than DLB.

Inclusion criteria for controls (patients with Alzheimer's disease (AD)):

• Probable AD (McKhann et al., 2011) or MCI-AD (Albert et al., 2011)
• Age > 50 years of age
• Able to give informed consent
• Able to cooperate as evaluated by the PI
• MCI, mild or moderate dementia, and MMSE > 18

Exclusion criteria for controls (patients with AD):

• Patients not able to give consent.
• Current alcohol or drug abuse
• Terminal illness
• Diagnosed with major neurological/psychiatric conditions other than AD.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease
• Mild Cognitive Impairment

Intervention

Diagnostic Test:
• Real-time quaking-induced conversion (RT-QuIC)
RT-QuIC measures the ability of alpha-synuclein (aSyn) to misfold other aSyn proteins and is an amplification technique.
• Cognitive test
Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA)
• Motor examination
Unified Parkinsons Rating Scale (UPDRS)

Locations

Country	Name	City	State
Denmark	Danish Dementia Research Centre	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Danish Dementia Research Centre	Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of Real-time quaking-induced conversion	Specificity	24 months
Primary	Diagnostic accuracy of Real-time quaking-induced conversion	Sensitivity	24 months
Primary	Diagnostic accuracy of Real-time quaking-induced conversion	Area under the curb	24 months
Secondary	Sense of smell	Test with Sniffin Sticks 16, Score 0- 16 points	24 months
Secondary	Dysautonomia	Unified Parkinsons Rating Scale part I 0-52	24 months
Secondary	Motor functions	Unified Parkinsons Rating Scale part III Score range: 0-132	24 months
Secondary	Cognitive function	Montreal Cognitive Assesment (MoCA) Score range: 0-30	24 months
Secondary	Cognitive function	Minimal Mental State Examination (MMSE) Score range: 0-30	24 months